Makers of Morning After Pill Ask FDA to Reconsider Drug's Over-the-Counter Status

( [email protected] ) Jul 27, 2004 05:39 PM EDT

The makers of the Plan B brand morning-after pill are asking the FDA to reconsider allowing the controversial birth control drug to be sold over-the-counter to girls as young as 16, revising an earlier proposal to give the pill a nonprescription status to all ages. The Food and Drug Administration rejected Barr Laboratories’ original proposal in May due to lack of data on the pill’s potential hazardous effects on young teens.

Barr filed the application on July 22 in response to FDA’s offer to reconsider the pill if Barr proposed to sell over-the-counter with the age restriction, or if it proved the pill's safety in younger girls. The 3rd largest U.S. maker of birth controls, Barr is setting January 22, 2005, as the deadline for the FDA to respond – the anniversary of the controversial Roe v. Wade decision that mandated abortion-on-demand.

According to Barr, if taken within 72 hours of a single act of unprotected sex, Plan B has an 89 percent rate in preventing a pregancy, leaving 11 percent risk of pregnancy. The morning-after pill is a high-dosage hormone pill of the traditional birth control bill used to prevent the uteral implantation of a fetilized egg but has no effect if a woman is already pregant.

Proponents of the pill say there is not enough time to get a doctor’s prescription for the drug before a pregnancy occurs and push for its over-the-counter availability, some promoting it as the second best alternative to an actual abortion.

Side effects of the pill include nausea. However, opponents of the pill have listed far more harmful effects of the pill.

The American College of Pediatricians wrote in a statement titled, "'Morning After' Pill -- A Risk to Pediatric Patients”:

“The American College of Pediatricians, a concerned group of science based child advocate physicians, strongly opposes unsupervised child and adolescent access to the ‘morning after pill’. We do so because we know the physical and emotional harm documented in children who undergo abortion procedures of any type. We are especially concerned about their ability to judge the need for, and deal with the consequences of, repeated use of these hormones to terminate an unimplanted but developing infant.”

A study from the United Kingdom provides a look at a wary future of greater social and health ills which resulted from making the morning-after pill available over-the-counter.

Released at the Royal Economic Society Conference in 2004, the study said, the “shift towards greater promotion of emergency birth control appears to have worsened the impact on STI [sexually transmitted infection] rates since 2000,” when the morning-after pill became available without prescription.

The pill and other measures aimed at reducing adolescent pregnancy rates did more harm than good, according to the study’s conclusion.

It “induced changes in teenage behavior that were large enough not only to negate the intended impact on pregnancy rates but to have an adverse impact on another important area of adolescent sexual health – sexually transmitted infections,” said the study.

“Regions that allow easy access to the morning-after pill experience an increase in the sexually transmitted disease rate and no decrease in abortions,” said Wendy Wright, senior policy director of Concerned Women for America, the nation’s largest women advocacy organization, known for its pro-family and pro-life stance.

Furthermore, by lifting restrictions on the pill, any person over 16 would be able to purchase it to use for anyone.

“The risk to minors is not alleviated by Barr’s scheme,” said Wright. “The person who buys the morning-after pill is not necessarily the person who would take it. An adult male who is sexually abusing a girl under 16 could buy the drug to cover up his crimes.”

Pro-life advocates object to the morning-after pill entirely. They believe that life begins at conception, thereby making contraceptives and abortive measures equivalent as killing.

When Barr submitted its initial proposal to the FDA for review in December 2003, forty-four members of Congress signed a letter to the FDA opposing the plan to grant the morning-after pill nonprescription, or over-the-counter, status.

"We urge you to reject the petition currently before you to make the morning-after pill as accessible to our nation's teenage daughters as aspirin or hairspray," the legislators wrote.

Currently, at the Democratic National Convention, pro-life issues are among the hot topics, drawing protesters and dividing the party.

In the U.S., the morning-after pill is available to women and young girls of all ages only by prescription with the exception of five states, including, Alaska, California, Hawaii, New Mexico and Washington, which sell the pill over-the-counter.